Replies to post #14342 on GTC Biotherapeutics (fka GTCB)

[pharm]

Dew, I can't understand why a FOB-partnership could be expected rather soon. The group of MAB on which GTC is focussing come only off patent over the next 6 to 8 years. So any potential partner is not in a hurry, especially not in these days of capital cruch

[DewDiligence]

Possible / Probable News Flow in 2008-2009

[Updated for 3Q08 CC and
proposed financing from LFB.]


1. Shareholder vote on proposed financing from LFB: 10-Dec-2008. The proposals are spelled out in the preliminary proxy statement filed with the SEC: http://sec.gov/Archives/edgar/data/904973/000119312508225996/dpre14a.htm .

2(a). FDA advisory panel for ATryn BLA: Jan 2009.
2(b). FDA PDUFA date for ATryn BLA: 7-Feb-2009. Possible actions on or before this date are approval for marketing, rejection, or a request for more information. Lately, the FDA has been routinely missing its PDUFA dates, so there is no assurance the FDA will actually render a decision by 2/7/09.

3. Update on the transfer of Leo’s ex-US ATryn rights to LFB. GTC has given no guidance on when this might occur; the sooner the better because the phase-2 DIC trial is on hold pending the outcome of these negotiations.

4. One or more FoB partnerships. There are several monoclonal antibodies with FoB potential in which GTC claims to have developed founder animals. GTC claims to have spoken to prospective FoB partners and hence a deal could come at any time. However, inking an FoB deal may have to wait for the political climate to improve (#msg-32325621).